ABSTRACT
This chapter covers regulatory controls applicable to design and
development (D&D) of medical devices in the pre-market phase,
also known as design controls. It includes an example of a market
access strategy template that can be used in the D&D planning stage.
The fundamentals of design inputs, design outputs, verification and
validation (V&V) and design transfer are explained. The chapter
concludes with an overview of identification and traceability for
medical devices and the Unique Device Identifier (UDI).
